Is NCT05443425 recruiting in Duarte, CA?

Yes, NCT05443425 is currently recruiting participants at its Duarte, CA location. This acute graft versus host disease clinical trial is actively enrolling qualified participants.

How do I join the acute graft versus host disease clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Graft Versus Host Disease Clinical Trial in Duarte, CA

About This Acute Graft Versus Host Disease Study in Duarte

This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Age \>= 18 years old

Karnofsky performance status \>= 70

Clinically suspected grade II-IV aGvHD based on Mount Sinai Acute GVHD International Consortium (MAGIC) Consensus criteria occurring after allogeneic hematopoietic cell transplantation (HCT) and GvHD prophylaxis regimen. Grade I acute (a)GvHD requiring systemic steroids is allowed. Clinical suspicion of aGvHD by the treating physician is sufficient, provided that alternative diagnosis of drug effects or infection are adequately ruled out

Note: HCT from any donor (related or unrelated with any degree of human leukocyte antigen \[HLA\] matching) and any graft source (bone marrow, peripheral blood stem cells, or cord blood) for hematologic malignancy or disorder. Recipient of myeloablative and reduced-intensity conditioning regimens are eligible

Biopsy of acute GvHD target organ is recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 72 hours from start of steroids are not permitted to participate

Evidence of myeloid engraftment (e.g., absolute neutrophil count \[ANC\] \>= 0.5 x 10\^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed

No prior systemic treatment for treatment of acute GvHD except for a maximum of 72 hours of prednisone =\< 2 mg/kg/day (or intravenous \[IV\] methylprednisone equivalent). Topical skin steroid treatment and non-absorbable oral steroid treatment for GI GvHD are permissible

Patients should be able to swallow and retain oral medication

Total bilirubin =\< 2 X ULN (unless has Gilbert's disease or aGvHD within 3 days of enrollment) (performed within 14 days prior to day 1 of protocol therapy)

Aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (performed within 14 days prior to day 1 of protocol therapy)

Alanine aminotransferase (ALT) =\< 3 x ULN (performed within 14 days prior to day 1 of protocol therapy)

Creatinine clearance of \>= 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy)

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion Criteria

Recipient of more than one allogeneic HCT

Received more than 3 days of systemic corticosteroid for treatment of aGvHD

Presence of GVHD overlap syndrome

Prior treatment with leflunomide

Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period

Use of other drugs for treatment of acute GvHD

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (leflunomide or cholestyramine)

Clinically significant uncontrolled illness

Patients on dialysis

Patient requiring ventilator support

Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributed to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection

Known history of immunodeficiency virus (HIV) infection

Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment, HBV deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) must be undetectable upon testing. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (i.e., hepatitis B surface antigen negative, surface antibody positive) may be used for purpose of eligibility and test do not need to be repeated. Subjects within prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown must have results confirming immune status before enrolment

Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allogeneic (allo)-HCT was performed

Severe organ dysfunction unrelated to underlying GvHD, including:

Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GvHD and ongoing organ dysfunction)

Clinically significant uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy

Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen

Non-hematologic malignancy within the past 3 years aside from the following exceptions:

Adequately treated basal cell or squamous cell skin cancer

Carcinoma in situ of the cervix

Prostate cancer \< Gleason Grade 6 with a stable prostate specific antigen (PSA)

Successfully treated in situ carcinoma of the breast

Females only: Pregnant or breastfeeding

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT05443425) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Graft Versus Host Disease Treatment Options in Duarte, CA

If you're searching for acute graft versus host disease treatment options in Duarte, CA, this clinical trial (NCT05443425) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced acute graft versus host disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute graft versus host disease clinical trials near you to find additional studies recruiting in your area.

Acute Graft Versus Host Disease Clinical Trial in Duarte, CA

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